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The E-Z-EM PROTOCO2L COLON Insufflator administers and regulates carbon dioxide (CO2) as a distention media to the colon during CT Colonography (CTC or Virtual Colonoscopy) and conventional Colonoscopy.

The EZEM PROTOCO>L with performance improvements, as with the predicate device is an insufflation system that is used in conjunction with a consumable and is intended to displace and regulate carbon dioxide (CO2) as a distention media to a patient's colon for purposes of CT Colonography and conventional colonoscopy. As with the predicate, the PROTOCO2L system with performance improvements consists of 3 components. These are the insufflator, consumable and accessory cart.

The provided document describes a 510(k) submission for the PROTOCOL™ Insufflator with Performance Improvements. This submission focuses on comparing the improved device to its predicate device to demonstrate substantial equivalence, rather than a standalone study proving novel acceptance criteria.

Therefore, many of the requested elements (like sample size for test/training sets, data provenance, number/qualification of experts, adjudication methods, MRMC studies, specific ground truth types) are NOT applicable or NOT explicitly stated in this type of regulatory submission. The document primarily highlights modifications to existing performance specifications and confirms that the indications for use remain the same.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents a comparison of the proposed device's performance specifications against the predicate device's specifications. The improvements themselves serve as the "acceptance criteria" for the new design, aiming to meet or exceed previous performance in specific areas while maintaining core functionalities.

2. Sample size used for the test set and the data provenance

• Not explicitly stated. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device based on design, material, and performance specifications. It does not typically include detailed study results with sample sizes for specific tests conducted on the modified device, unless a new clinical trial was deemed necessary (which appears not to be the case here, as it's a "special 510(k)"). The performance improvements are described as design changes substantiated by technical data, likely bench testing or engineering verification rather than a clinical human subject study testing the acceptance criteria.
• Data provenance: Not specified, but likely from in-house engineering and bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable/Not stated. This type of information would be relevant for studies evaluating a device's diagnostic accuracy or clinical effectiveness against a gold standard, often involving expert review of images or clinical outcomes. For modifications to an insufflator that primarily affect flow, pressure, and volume delivery mechanisms, the "ground truth" is established through physical measurements and engineering standards rather than expert consensus on diagnostic images.

4. Adjudication method for the test set

• Not applicable/Not stated. Adjudication methods like 2+1 or 3+1 are used in studies where multiple experts evaluate cases and a consensus is needed to establish ground truth or resolve discrepancies in interpretations (e.g., in diagnostic AI studies). This is not relevant for the type of engineering verification demonstrated in this 510(k) submission.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. This device is an insufflator, not an AI-powered diagnostic tool. MRMC studies are used to evaluate changes in human reader performance (e.g., radiologists) when assisted by AI. This is entirely outside the scope of this device and submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This question pertains to AI algorithms. The PROTOCOL™ Insufflator is a medical device for physical CO2 delivery, not an algorithm.

7. The type of ground truth used

• For the performance specifications (flow rate, pressure relief, volume delivery logic, accuracy figures), the "ground truth" would be established through engineering measurements and calibration standards. This involves using validated equipment to measure CO2 flow, pressure, and volume output from the device under specified conditions and comparing these measurements against the defined performance specifications. Compliance with international safety and EMC standards (IEC/EN60601-1, IEC/EN 60601-1-2) would also be verified through standardized testing procedures.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of this device. Training sets are relevant for machine learning algorithms, which is not what this device is.

9. How the ground truth for the training set was established

• Not applicable. As stated above, this device does not involve machine learning or training sets.

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